The FDA de-regulates the first genetically-engineered animal

By Joanna Sax

On November 19, 2015, the FDA de-regulated the AquAdvantage Salmon.  This salmon is genetically engineered to grow faster.  This is the first time the FDA has de-regulated a genetically engineered animal.

Let me just say from the outset that the scientific consensus is clear that genetically engineered food is as safe as conventional food.  Despite the onslaught of public outrage against GMO food, most of the main arguments against GMO food are just hype.

The genie came out of the bottle a long time ago and it’s not going back in.  This happens time and again with scientific advances.   Over the past few decades, our ability to understand, manipulate, edit, and otherwise employ the DNA of various organisms to facilitate human understanding has grown exponentially.  Efforts to resist, combat, or villain-ize the application of biotechnology to impact society might delay, but will not ultimately succeed in keeping the application of scientific discoveries at bay.

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DCIS Study Amplifies Questions and Demand for Answers

By Dalia Deak

This week, a JAMA Oncology article made a splash when it intensified discussion around what ductal carcinoma in situ (DCIS) should be considered – cancer, precursor, or risk factor – and whether current treatment approaches have been effective. The New York Times, The Guardian, and others have picked up the story, and readers have reacted extensively, only amplifying a demand for answers to questions raised.

Often called Stage 0 breast cancer, DCIS is considered to be abnormal cells that are confined inside the milk ducts and, as such, are not considered invasive. Because of the increased risk associated with DCIS, many women who are found to have DCIS (a growing number considering the frequency of and improvements in mammography) undergo lumpectomies or mastectomies often accompanied by radiation therapy. Continue reading

Interpreting Fiorina’s Comments on Vaccination Law

By Michelle Meyer

I’ve started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She’s Right, analyzes GOP presidential candidate Carly Fiorina’s recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina’s remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others’ views, especially on contentious issues like vaccination.

What Should the Future Look Like for Brain-Based Pain Imaging in the Law? Three Eminent Scholars Weigh In

By Amanda C. Pustilnik, Professor of Law, University of Maryland Carey School of Law; Faculty Member, Center for Law, Brain & Behavior, Massachusetts General Hospital

What should the future look like for brain-based pain measurement in the law?  This is the question tackled by our concluding three contributors:  Diane Hoffmann, Henry (“Hank”) T. Greely, and Frank Pasquale. Professors Hoffmann and Greely are among the founders of the fields of health law and law & biosciences. Both discuss parallels to the development of DNA evidence in court and the need for similar standards, practices, and ethical frameworks in the brain imaging area.  Professor Pasquale is an innovative younger scholar who brings great theoretical depth, as well as technological savvy, to these fields.  Their perspectives on the use of brain imaging in legal settings, particularly for pain measurement, illuminate different facets of this issue.

This post describes their provocative contributions – which stake out different visions but also reinforce each other.  The post also highlights the forthcoming conference-based book with Oxford University Press and introduces future directions for the use of the brain imaging of pain – in areas as diverse as the law of torture, the death penalty, drug policy, criminal law, and animal rights and suffering.  Please read on!

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Neuroimaging as Evidence of Pain: It’s Time to Prepare

By Henry T. Greely, Edelman Johnson Professor of Law, Stanford Law School; Professor (by courtesy) of Genetics, Stanford Medical School; Director, Program in Neuroscience & Society, Stanford University

The recent meeting at Harvard on neuroimaging, pain, and the law demonstrated powerfully that the offering of neuroimaging as evidence of pain, in court and in administrative hearings, is growing closer. The science for identifying a likely pattern of neuroimaging results strongly associated with the subjective sensation of pain keeps improving. Two companies (and here) recently were founded to provide electro-encephalography (EEG) evidence of the existence of pain. And at least one neuroscientist has been providing expert testimony that a particular neuroimaging signal detected using functional magnetic resonance imaging (fMRI) is useful evidence of the existence of pain, as discussed recently in Nature.

If nothing more is done, neuroimaging evidence of pain will be offered, accepted, rejected, relied upon, and discounted in the normal, chaotic course of the law’s evolution. A “good” result, permitting appropriate use of some valid neuroimaging evidence and rejecting inappropriate use of other such evidence, might come about. Or it might not.

We can do better than this existing non-system. And the time to start planning a better approach is now. (Read on for more on how)

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New York Times Op-Ed on the A/B Illusion & the Virtues of Data-Driven Innovation

By Michelle Meyer

I have an op-ed with Christopher Chabris that appeared in this past Sunday’s New York Times. It focuses on one theme in my recent law review article on corporate experimentation: the A/B illusion. Despite the rather provocative headline that the Times gave it, our basic argument, made as clearly as we could in 800 words, is this: sometimes, it is more ethical to conduct a nonconsensual A/B experiment than to simply go with one’s intuition and impose A on everyone. Our contrary tendency to see experiments—but not untested innovations foisted on us by powerful people—as involving risk, uncertainty, and power asymmetries is what I call the A/B illusion in my law review article. Here is how the op-ed begins:

Can it ever be ethical for companies or governments to experiment on their employees, customers or citizens without their consent? The conventional answer — of course not! — animated public outrage last year after Facebook published a study in which it manipulated how much emotional content more than half a million of its users saw. Similar indignation followed the revelation by the dating site OkCupid that, as an experiment, it briefly told some pairs of users that they were good matches when its algorithm had predicted otherwise. But this outrage is misguided. Indeed, we believe that it is based on a kind of moral illusion.

After the jump, some clarifications and further thoughts.

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The Ethics of Punking the Diet-Research Media Complex (and Millions of Readers)


By Michelle Meyer

A remarkable new “sting” of the “diet research-media complex” was just revealed. It tells us little we didn’t already know and has potentially caused a fair amount of damage, spread across millions of people. It does, however, offer an opportunity to explore the importance of prospective group review of non-consensual human subjects research—and the limits of IRBs applying the Common Rule in serving that function in contexts like this.

Journalist John Bohannon, two German reporters, a doctor and a statistician recruited 16 German subjects through Facebook into a three-week randomized controlled trial of diet and weight loss. One-third were told to follow a low-carb diet, one-third were told to cut carbs but add 1.5 ounces of dark chocolate (about 230 calories) per day, and one-third served as control subjects and were told to make no changes to their current diet. They were all given questionnaires and blood tests in advance to ensure they didn’t have diabetes, eating disorders, or other conditions that would make the study dangerous for them, and these tests were repeated after the study. They were each paid 150 Euros (~$163) for their trouble.

But it turns out that Bohannon, the good doctor (who had written a book about dietary pseudoscience), and their colleagues were not at all interested in studying diet. Instead, they wanted to show how easy it is for bad science to be published and reported by the media. The design of the diet trial was deliberately poor. It involved only a handful of subjects, had a poor balance of age and of men and women, and so on. But, through the magic of p-hacking, they managed several statistically significant results: eating chocolate accelerates weight loss and leads to healthier cholesterol levels and increased well-being. Continue reading

New paper on cross-disciplinary collaboration

By Timo Minssen

The nature of today’s most vital challenges and funding policies are driving more and more researchers towards interdisciplinary work. But what are the essential tools for those breaking the silos and leaving the comfort zones of their own disciplines?

Some advice on how to address the particular challenges and opportunities in interdisciplinary research are described in our recent paper “Ten Simple Rules for a Successful Cross-Disciplinary Collaboration” published in the online open access journal PLOS Computational Biology last month. Please find below and abstract of the paper, which has inter alia been discussed and cited by Times Higher Education.


Cross-disciplinary collaborations have become an increasingly important part of science. They are seen as a key factor for finding solutions to pressing societal challenges on a global scale including green technologies, sustainable food production and drug development. This has also been realized by regulators and policy-makers, as it is reflected in the 80 billion Euro “Horizon 2020” EU Framework Programme for Research and Innovation. This programme puts special emphasis at breaking down barriers between fields to create a path breaking environment for knowledge, research and innovation.

However, igniting and successfully maintaining cross-disciplinary collaborations can be a delicate task. In this article we focus on the specific challenges associated with cross-disciplinary research in particular from the perspective of the theoretician. As research fellows of the 2020 Science project and collaboration partners, we bring broad experience of developing interdisciplinary collaborations [2–12]. We intend this guide for early career computational researchers as well as more senior scientists who are entering a cross disciplinary setting for the first time. We describe the key benefits, as well as some possible pitfalls, arising from collaborations between scientists with backgrounds in very different fields.

Proposed citation:

Knapp B, Bardenet R, Bernabeu MO, Bordas R, Bruna M, Minssen T, et al. (2015) Ten Simple Rules for a Successful Cross-Disciplinary Collaboration. PLoS Comput Biol 11(4): e1004214. doi:10.1371/journal.pcbi.1004214

Two Cheers for Corporate Experimentation

Rubin's vase2By Michelle Meyer

I have a new law review article out, Two Cheers for Corporate Experimentation: The A/B Illusion and the Virtues of Data-Driven Innovation, arising out of last year’s terrific Silicon Flatirons annual tech/privacy conference at Colorado Law, the theme of which was “When Companies Study Their Customers.”

This article builds on, but goes well beyond, my prior work on the Facebook experiment in Wired (mostly a wonky regulatory explainer of the Common Rule and OHRP engagement guidance as applied to the Facebook-Cornell experiment, albeit with hints of things to come in later work) and Nature (a brief mostly-defense of the ethics of the experiment co-authored with 5 ethicists and signed by an additional 28, which was necessarily limited in breadth and depth by both space constraints and the need to achieve overlapping consensus).

Although I once again turn to the Facebook experiment as a case study (and also to new discussions of the OkCupid matching algorithm experiment and of 401(k) experiments), the new article aims at answering a much broader question than whether any particular experiment was legal or ethical. Continue reading

Is concussion protection in Florida too much, too soon?

Today’s New York Times featured a long exploration of “Headgear Rule for Girls’ Lacrosse Ignites Outcry.” As a former lacrosse player and health policy researcher, I read the piece with interest.

Essentially what’s happened is that Florida has instituted a headgear rule ahead of the sport’s national governing body. Florida made this decision in advance of this season based on statistics that show that female lacrosse players experience the fifth-highest rate of concussions of any high school athlete. If you’ve ever held a lacrosse ball, this won’t surprise you.

Still, it is not immediately clear what the actual rate of concussions is in Florida. Identifying girls lacrosse as coming in 5th place doesn’t help the reader judge how pervasive the risk really is if we consider that there could be large gaps between the ordinal rankings. Florida officials have suggested that if even one injury is prevented by the introduction of headgear, the rule would be worth it. I’m not sure I’m so risk-averse. Continue reading

Bioethicist Art Caplan: Why a New Alzheimer’s Drug Isn’t A No-Brainer

A new piece by contributor Art Caplan on NBC News:

Biogen, a Cambridge, Massachusetts biotech company, announced last week that early tests of their new drug aducanumab, a monoclonal antibody, had shown impressive results in treating those with early stage Alzheimer’s disease. The drug significantly reduced the amyloid plaque buildup in the brain that is associated with Alzheimer’s.

In a very early stage safety test aducanumab slowed the cognitive decline and dementia associated with Alzheimer’s in people. On the Mini Mental Status Exam, a widely used measure of cognitive function, people at risk of Alzheimer’s who got a placebo lost around 3 points over a year. But those who got the lowest dose of aducanumab worsened by just two points and those who got a higher dose lost less than a point.

Biogen was so excited by the early results in 166 volunteers that it is going to try to go directly to a much bigger clinical trial of the drug. Wall Street was very excited too—Biogen’s stock price shot up 10 percent. […]

See the full article here.

Studies provide new insights into youth and adolescent concussion

By: Christine Baugh

In the past several weeks there have been two studies with important implications for youth and adolescent concussions. They are summarized briefly in this post.

Post-Concussion Rest. Thomas and colleagues recently published a study in the journal Pediatrics examining whether standard of care (1-2 days rest) or 5 days of strict rest (both physical and cognitive) following concussion led to better short-term health outcomes in a population of 11-22 year old patients. The full text of this manuscript is available here. Expert consensus recommends strict rest –of relatively undefined duration — followed by a gradual return to cognitive and then physical activity. The study’s authors hypothesized that increased rest would improve outcomes, but found that the strict rest group did not have measurable health improvements compared to standard of care. In fact, symptom reporting was modestly higher in the strict rest group. Main study limitations include: small sample size and short follow-up period (which does not allow for insight as to longer term implications). This was the first randomized control trial of rest duration following concussion diagnosis in a youth and adolescent cohort, and the study added critical information to an important area of inquiry. Continue reading

Two new publications on “European patent strategies under the UPCA” and on “Synthetic Biology & Intellectual Property Rights”

By Timo Minssen

I am pleased to announce two new publications on (1) “European patent strategies under the UPCA” and (2)  “Synthetic Biology & Intellectual Property Rights”:

1) Minssen, T & Lundqvist, B 2014, ‘The ”opt out” and “opt-in” provisions in the Unified Patent Court Agreement – Impact and strategies for European patent portfolios‘ , published  in N I R (Nordic IP Review), vol 2014, nr. 4, s. 340-357.

Abstract: Many questions concerning the UPC’s jurisdiction during the transitional period for European Patents under Article 83 UPCA remain unsolved. Focusing on the “opt in” and “opt out” choices under Article 83 (3) & (4), this paper discusses the legal nature and prerequisites of these provisions, as well as the options and strategic choices that patent proprietors and applicants are facing. Considering the pros and cons of the emerging unitary system in light of a persisting uncertainty of how to interpret relevant stipulations, it is emphasized that there will be no clear-cut solutions. Rather the suitability of each approach will have to be evaluated on a case-by-case basis, taking into account all circumstances surrounding an invention, its patent-claims and the underlying business strategy. Recognizing that the worst thing to do is to do nothing at all, we conclude with a summary and some general remarks.

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Arthur Caplan on Hyperbaric Oxygen Therapy

Art Caplan has a new piece on hyperbaric oxygen therapy over at NBC News:

Hyperbaric oxygen therapy. Have you ever heard of it? The Internet sure has.

Centers and clinics tout the benefits of sitting in a tank breathing 100 percent oxygen at higher than atmospheric pressure for treating autism, infant brain trauma, multiple sclerosis, chronic fatigue, cerebral palsy and many other conditions.

There’s just one problem: There is no solid evidence that hyperbaric oxygen therapy does anything for any of these disorders.

Read the full article here.

Will the Real Evidence-Based Ebola Policy Please Stand Up? Seven Takeaways From Maine DHHS v. Hickox

By Michelle Meyer

Ebola pic

The case I mentioned in my last post, Maine Department of Health and Human Services v. Kaci Hickox is no more. Hickox and public health officials agreed to stipulate to a final court order imposing on Hickox the terms that the court had imposed on her in an earlier, temporary order. Until Nov. 10, when the 21-day incubation period for Ebola ends, Hickox will submit to “direct active monitoring” and coordinate her travel with Maine public health authorities to ensure that such monitoring occurs uninterrupted. She has since said that she will not venture into town or other public places, although she is free to do so.

In a new post at The Faculty Lounge,* I offer a detailed account of the case, which suggests the following lessons:

  1. As Hickox herself described it, the result of her case is a “compromise,” reflecting neither what Hickox nor what Maine initially wanted.
  2. That compromise was achieved by the parties availing themselves of the legal process, not through Hickox’s civil disobedience.
  3. The compromise is not easily described, as it has been, as a victory of science-based federal policy over fear-based state demagoguery. By the time the parties got to court, and perhaps even before then, what Maine requested was consistent with U.S. CDC Guidance, albeit a strict application of it. What Hickox had initially offered to do, by contrast, fell below even the most relaxed application of those guidelines, although by the time the parties reached court, she had agreed to comply with that minimum.
  4. The compromise applies only to Hickox, and was based on a stipulation by the parties to agree to the terms that the court had temporarily imposed after reviewing a limited evidentiary record. Additional evidence and legal arguments that the state might have raised in the now-cancelled two-day hearing could have resulted in a different outcome.
  5. A substantially different outcome, however, would have been unlikely under Maine’s public health statute. Indeed, it is not clear that Maine’s public health statute allows public health authorities to compel asymptomatic people at-risk of developing Ebola to do anything, including complying with minimum CDC recommendations.
  6. “Quarantine” is a charged, but ambiguous, term. It allows us to talk past one another, to shorthand and needlessly politicize a much-needed debate about appropriate policy, and to miss the fact that the CDC Guidance in some cases recommends what could be fairly described as a “quarantine” for people like Hickox and requires it for asymptomatic people with stronger exposure to Ebola (but who are still probably less likely to get sick than not).
  7. It’s not clear who has bragging rights to Ebola policy “grounded in science,” or what that policy looks like.

* The piece is quite long, and I cannot bear the fight with the WordPress formatting demons that it would require to cross-post it here.

Above the (Public Health) Law: Healthcare Worker Deception and Disobedience in a Time of Distrust

By Michelle Meyer

[Author’s Note: Addendum and updates (latest: 4  pm, 10/31) added below.]

A physician shall… be honest in all professional interactions, and strive to report physicians… engaging in fraud or deception, to appropriate entities.
AMA Principles of Medical Ethics

This is a troubling series of news reports about deception and defiance on the part of some healthcare workers (HCWs) in response to what they believe to be unscientific, unfair, and/or unconstitutional public health measures (to be clear, the text is not mine (until after the jump); it’s cut and pasted, in relevant part, from the linked sources):

(1) Ebola Aide Doc: I’m Not Telling My Team To Tell The Truth

Gavin Macgregor-Skinner, an epidemiologist and Global Projects Manager for the Elizabeth R. Griffin Foundation, who has led teams of doctors to treat Ebola in West Africa, reported that he “can’t tell them [his doctors] to tell the truth [to U.S. officials]” on Monday’s “CNN Newsroom.”

“At the moment these people are so valuable . . . I have to ensure they come back here, they get the rest needed. I can’t tell them to tell the truth at the moment because we’re seeing so much irrational behavior,” he stated. “I’ve come back numerous times between the U.S. and West Africa. If I come back now and say ‘I’ve been in contact with Ebola patients,’ I’m going to be locked in my house for 21 days,” Macgregor-Skinner said as his reason for not being truthful with officials, he added, “when I’m back here in the US, I am visiting US hospitals everyday helping them get prepared for Ebola. You take me out for three weeks, who’s going to replace me and help now US hospitals get ready? Those gaps can’t be filled.

He argued that teams of doctors and nurses could be trusted with the responsibility of monitoring themselves, stating, “When I bring my team back we are talking each day on video conferencing, FaceTime, Skype, text messaging, supporting each other. As soon as I feel sick I’m going to stay at home and call for help, but I’m not going to go to a Redskins game here in Washington D.C. That’s irresponsible, but I need to get back to these hospitals and help them be prepared.

UPDATE: Here is the CNN video of his remarks.

(2) Ebola Doctor ‘Lied’ About NYC Travels

The city’s first Ebola patient initially lied to authorities about his travels around the city following his return from treating disease victims in Africa, law-enforcement sources said. Dr. Craig Spencer at first told officials that he isolated himself in his Harlem apartment — and didn’t admit he rode the subways, dined out and went bowling until cops looked at his MetroCard the sources said. “He told the authorities that he self-quarantined. Detectives then reviewed his credit-card statement and MetroCard and found that he went over here, over there, up and down and all around,” a source said. Spencer finally ’fessed up when a cop “got on the phone and had to relay questions to him through the Health Department,” a source said. Officials then retraced Spencer’s steps, which included dining at The Meatball Shop in Greenwich Village and bowling at The Gutter in Brooklyn.

Update 11PM, 10/30: A spokesperson for the NYC healh department has now disputed the above story, which cites anonymous police officer sources, in a statement provided to CNBC. The spokesperson said: “Dr. Spencer cooperated fully with the Health Department to establish a timeline of his movements in the days following his return to New York from Guinea, providing his MetroCard, credit cards and cellphone.” . . . When CNBC asked again if Spencer had at first lied to authorities or otherwise mislead them about his movements in the city, Lewin replied: “Please refer to the statement I just sent. As this states, Dr. Spencer cooperated fully with the Health Department.”

(3) Ebola nurse in Maine rejects home quarantine rules [the WaPo headline better captures the gist: After fight with Chris Christie, nurse Kaci Hickox will defy Ebola quarantine in Maine]

Kaci Hickox, the Ebola nurse who was forcibly held in an isolation tent in New Jersey for three days, says she will not obey instructions to remain at home in Maine for 21 days. “I don’t plan on sticking to the guidelines,” Hickox tells TODAY’s Matt Lauer. “I am not going to sit around and be bullied by politicians and forced to stay in my home when I am not a risk to the American public.”

Maine health officials have said they expect her to agree to be quarantined at her home for a 21-day period. The Bangor Daily News reports. But Hickox, who agreed to stay home for two days, tells TODAY she will pursue legal action if Maine forces her into continued isolation. “If the restrictions placed on me by the state of Maine are not lifted by Thursday morning, I will go to court to fight for my freedom,” she says.

Some thoughts on these reports, after the jump.  Continue reading

The Ebola “Czar”

By David Orentlicher
[Cross-posted at Health Law Profs and PrawfsBlawg.]

In the wake of Craig Spencer’s decision to go bowling in Brooklyn, governors of three major states—Illinois, New Jersey, and New York—have imposed new Ebola quarantine rules that are inconsistent with national public health policy, are not likely to protect Americans from Ebola, and may compromise the response to Ebola in Africa, as health care providers may find it too burdensome to volunteer where they are needed overseas. Don’t we have an Ebola czar who is supposed to ensure that our country has a coherent and coordinated response to the threat from Ebola?

Of course, the term “czar” was poorly chosen precisely because Ron Klain does not have the powers of a czar. He will oversee the federal response to Ebola, but he cannot control the Ebola policies of each state. Unfortunately, on an issue that demands a clear national policy that reflects medical understanding, public anxieties will give us something much less desirable.

Facebook Announces New Research Policies


By Michelle Meyer

A WSJ reporter just tipped me off to this news release by Facebook regarding the changes it has made in its research practices in response to public outrage about its emotional contagion experiment, published in PNAS. I had a brief window of time in which to respond with my comments, so these are rushed and a first reaction, but for what they’re worth, here’s what I told her (plus links and less a couple of typos):

There’s a lot to like in this announcement. I’m delighted that, despite the backlash it received, Facebook will continue to publish at least some of their research in peer-reviewed journals and to post reprints of that research on their website, where everyone can benefit from it. It’s also encouraging that the company acknowledges the importance of user trust and that it has expressed a commitment to better communicate its research goals and results.

As for Facebook’s promise to subject future research to more extensive review by a wider and more senior group of people within the company, with an enhanced review process for research that concerns, say, minors or sensitive topics, it’s impossible to assess whether this is ethically good or bad without knowing a lot more about both the people who comprise the panel and their review process (including but not limited to Facebook’s policy on when, if ever, the default requirements of informed consent may be modified or waived). It’s tempting to conclude that more review is always better. But research ethics committees (IRBs) can and do make mistakes in both directions – by approving research that should not have gone forward and by unreasonably thwarting important research. Do Facebook’s law, privacy, and policy people have any training in research ethics? Is there any sort of appeal process for Facebook’s data scientists if the panel arbitrarily rejects their proposal? These are the tip of the iceberg of challenges that the academic IRBs continue to face, and I fear that we are unthinkingly exporting an unhealthy system into the corporate world. Discussion is just beginning among academic scientists, corporate data scientists, and ethicists about the ethics of mass-scale digital experimentation (see, ahem, here and here). It’s theoretically possible, but unlikely, that in its new, but unclear, guidelines and review process Facebook has struck the optimal balance among the competing values and interests that this work involves.  Continue reading

Are we appropriately framing the risks of brain trauma in contact sports?

By Christine Baugh

The recent concussion and sport special issue of the Journal of Law Medicine and Ethics (generously made available free by the American Society of Law Medicine and Ethics: HERE), edited by new Bill of Health contributor David Orentlichter,  includes a number of important works discussing legal and ethical issues related to mild traumatic brain injury sustained through sport. One of the most thought provoking articles in the issue is a piece by Kathleen Bachynski and Daniel Goldberg titled Youth Sports & Public Health: Framing Risks of Mild Traumatic Brain Injury in American Football and Ice Hockey. This piece delves into the important issues of cultural and normative influences on the framing (and thus public understanding) of the risk of brain injury in sport. At the heart of the paper is the assertion that, “The framing of risk is not a neutral, apolitical enterprise,” and that in the United States and Canada highly influential institutional actors such as football and ice hockey leagues have played a formative role in the cultural valuation of the risks inherent in these activities.

Bachynski and Goldberg provide a variety of examples where the overarching questions such as “Are contact sports too risky?” or “What is an appropriate level of risk?” are deferred for easier alternatives. Addressing more focal issues are: State concussion laws which mandate secondary prevention measures, advancement in protective equipment which promises to mitigate risk of injury, rule changes made by sports leagues which aim to make inherently dangerous activities somewhat less dangerous. Rather than addressing the broader risk questions, the implicit assumption in these more focused efforts is that risks are acceptable as long as they are managed. Through what Bachynski and Goldberg assert are concerted efforts on behalf of major stakeholders (e.g., major sports leagues), this has been the predominant frame for risk assessment in contact sports.

Unfortunately, this method of framing risks is not without consequences. Bachynski and Goldberg argue that this framing may alter our understanding of the scope of the problem as well as the most appropriate interventions or solutions. This frame may also inappropriately downplay the need to address the broader moral, social, and political questions that arise from concussions in contact sports. For example, the authors pose the following question, “At what age can players consent to risks of head trauma and associated elevated risks of chronic degenerative neurological disease?”

Answering this question could require a complex weighing of the scientific evidence of the long-term risk of neurodegeneration and balancing it against a variety of factors such as the paternalistic desire to control the population’s ability to partake in self-injurious behavior and the need to protect an individual’s autonomy. (We do, after all, regularly let individuals partake in other dangerous activities—e.g., downhill skiing or driving a car.) We would need to think about questions such as: Should we treat the risk of brain injury differently than bodily injury? Should the risk of delayed or chronic injury be weighed differently given humans’ known difficulty in assessing risk in the distant future? What does scientific evidence have to say about the nature of the risk across age ranges? However, under the current framing these questions are not the ones being addressed. Bachynski and Goldberg’s article elucidates the first step toward addressing concussions from sport: appropriately framing the problem.

[This post reflects my own views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

Fall Facebook/OKCupid and Future of Research Tour

Sept. 18 Tweet Chat

By Michelle Meyer

I’m participating in several public events this fall pertaining to research ethics and regulation, most of them arising out of my recent work (in Wired and in Nature and elsewhere) on how to think about corporations conducting behavioral testing (in collaboration with academic researchers or not) on users and their online environments (think the recent Facebook and OKCupid experiments). These issues raise legal and ethical questions at the intersection of research, business, informational privacy, and innovation policy, and the mix of speakers in most of these events reflect that.  Continue reading